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Regulatory Information
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Clinical Trials Guidance Documents
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Guidance Documents:
- 07/2009 Frequently Asked Questions - IRB Registration (PDF - 181KB)
- 09/2005 Collection of Race and Ethnicity Data in Clinical Trials
- 01/1988 Monitoring Clinical Investigations
- 04/1999 Computerized Systems Used in Clinical Trials
- 01/2006 Significant Risk and Nonsignificant Risk Medical Device Studies - Information Sheet (PDF - 121KB)
- 01/1998 Institutional Review Boards Frequently Asked Questions - Information Sheet
- 01/1998 Cooperative Research - Information Sheet
- 01/1998 Non-local IRB Review - Information Sheet
- 01/1998 Continuing Review After Study Approval - Information Sheet
- 01/1998 Sponsor - Investigator - IRB Interrelationship - Information Sheet
- 01/1998 Acceptance of Foreign Clinical Studies - Information Sheet
- 01/1998 Charging for Investigational Products - Information Sheet
- 01/1998 Recruiting Study Subjects - Information Sheet
- 01/1998 Payment to Research Subjects - Information Sheet
- 01/1998 Screening Tests Prior to Study Enrollment - Information Sheet
- 01/1998 A Guide to Informed Consent - Information Sheet
- 01/1998 Use of Investigational Products When Subjects Enter a Second Institution - Information Sheet
- 01/1998 Exception from Informed Consent for Studies Conducted in Emergency Settings: Regulatory Language and Excerpts from Preamble - Information Sheet
- 01/1998 "Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices - Information Sheet
- 01/1998 Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials - Information Sheet (PDF - 399KB)
- 01/1998 Emergency Use of an Investigation Drug or Biologic - Information Sheet
- 01/1998 Treatment Use of Investigational Drugs - Information Sheet
- Waiver of IRB Requirements for Drug and Biological Product Studies - Information Sheet (PDF - 35KB)
- 01/1998 Drug Study Designs - Information Sheet
- 01/1998 Evaluation of Gender Differences in Clinical Investigations - Information Sheet
- 01/2006 FDA Inspections of Clinical Investigators - Information Sheet (PDF - 48KB)
- 01/2006 FDA Institutional Review Board Inspections - Information Sheet (PDF - 45KB)
- 01/1998 Clinical Investigator Regulatory Sanctions - Information Sheet
- 01/2007 FDA/NCI MOU Regarding Common Standards-based Data Repository (PDF - 312KB)
- Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection
- 01/2009 Adverse Event Reporting to IRBs - Improving Human Subject Protection (PDF - 79KB)
- 12/2006 Process for Handling Referrals to FDA under 21 CFR 50.54 (PDF - 76KB)
- 03/2006 Establishment and Operation of Clinical Trial Data Monitoring Committees (PDF - 194KB)
- 07/2004 Available Therapy
- 03/2005 Development and Use of Risk Minimization Action Plans (PDF - 84KB)
- 03/2001 Financial Disclosure by Clinical Investigators
- 12/2002 Food-Effect Bioavailability and Fed Bioequivalence Studies (PDF - 166KB)
- 03/2005 Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (PDF - 220KB)
- 07/1993 Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs (PDF - 1875KB)
- 05/2004 Handling and Retention of Bioavailability and Bioequivalence Testing Samples; Availability (PDF - 166KB)
- 01/2004 IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (PDF - 188KB)
- 03/2002 Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (PDF - 34KB)
- 10/2003 IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations (PDF - 614KB)
- 08/2003 Electronic Records; Electronic Signatures - Part 11, Scope and Application (PDF - 215KB)
- 01/2002 General Principles of Software Validation
- 03/2005 Pharmacogenomic Data Submissions (PDF - 96KB)
- 03/2005 Premarketing Risk Assessment (PDF - 91KB)
- 10/2005 Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
- 09/2004 The Use of Clinical Holds Following Clinical Investigator Misconduct (PDF - 33KB)
- 03/2006 Using a Centralized IRB Review Process in Multicenter Clinical Trials
- 04/2006 Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
- 01/2006 Frequently Asked Questions About Medical Devices - Information Sheet (PDF - 105KB)
- 03/2006 The Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical Trial Sponsors
- 08/2004 Independent Consultants for Biotechnology Clinical Trial Protocols
- 04/2007 Adverse Event Reporting - Improving Human Subject Protection
- 02/2005 Clinical Lactation Studies - Study Design, Data Analysis, and Recommendations for Labeling
- 01/2006 Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products - Content and Format
- 10/2000 Submitting and Reviewing Complete Responses to Clinical Holds
- 12/2006 Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional Safeguards for Children in Clinical Investigations
- 07/2006 Exception from Informed Consent Requirements for Emergency Research
- 05/2007 Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators
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